Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Exactech® Alteon® HA Femoral Stem

K-Number: K162732 · 2017-04-26

ApplicantExactech, Inc.
Decision Date2017-04-26
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Alteon® HA Femoral Stem is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2017-04-26 under approval number K162732. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Alteon® HA Femoral Stem?

Exactech® Alteon® HA Femoral Stem is a medical device that received FDA 510(k) clearance on 2017-04-26. It is manufactured by Exactech, Inc.. The 510(k) number is K162732.

When was Exactech® Alteon® HA Femoral Stem approved by the FDA?

Exactech® Alteon® HA Femoral Stem received FDA 510(k) clearance on 2017-04-26, under approval number K162732.

What company makes Exactech® Alteon® HA Femoral Stem?

Exactech® Alteon® HA Femoral Stem is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Alteon® HA Femoral Stem?

The FDA product code for Exactech® Alteon® HA Femoral Stem is MEH.

Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

View all 41 devices →

Related Devices (Code: MEH)

K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. K160011H-Max S stemLima Corporate S.P.A. K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd. K160907DePuy Actis DuoFix Hip ProsthesisDepuy(Ireland) K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd. K153772Corin TriFit TS HipCorin U.S.A. Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑